Gloves intended to protect patients and health workers can themselves introduce a hazard. In its final rule published December 19, 2016, FDA concluded that powdered surgical gloves, powdered patient-examination gloves and absorbable powder for lubricating surgical gloves posed unreasonable and substantial risks that labeling could not correct. The specified effective date was January 18, 2017. [2016-30382][2016-06360]

FDA described inflammation, granulomas and respiratory allergic reactions among the risks associated with glove powder. Its decision targeted the listed powdered products, not all medical gloves or all latex gloves. Non-powdered surgical and examination gloves remained outside the banned categories; powdered radiographic gloves were also excluded. Those boundaries matter when communicating a workplace protection measure without suggesting every protective glove is suspect. [2016-30382][2016-06360]

The March 22 proposal placed the decision in a longer evidentiary history. It recounted FDA's 1997 review of clinical and experimental information, MedWatch adverse-event reports and then-available market information about glove types and costs. That history shows the agency considered both exposure and alternatives. It should not be read as proof that market constraints described for 1997 still existed in 2016. [2016-30382][2016-06360]

The final effective-date provision reached devices already distributed or sold to users, as well as future sales and distribution. Earlier purchase was not a general exemption. For patients and staff, the public-interest distinction is between changing the product offered and merely adding a warning. The proposal and final rule show one FDA decision process, not two independent clinical assessments or evidence that injuries had already fallen after the ban. [2016-30382][2016-06360]

Source documents

  1. Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glovehttps://www.govinfo.gov/content/pkg/FR-2016-12-19/html/2016-30382.htm
  2. Banned Devices; Proposal To Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glovehttps://www.govinfo.gov/content/pkg/FR-2016-03-22/html/2016-06360.htm